Identity
- Trade Name
- Thyroid Stimulating Hormone (TSH) ELISA FDA UDI
- Generic Name
- Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Thyroid Stimulating Hormone (TSH) ELISA is intended for use in the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders. FDA UDI
- Model / Reference
- 25-TSHHU-E01 FDA UDI
- Description
- The Thyroid Stimulating Hormone (TSH) ELISA is intended for use in the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders. FDA UDI
Identifiers
- Catalog Number
- 25-TSHHU-E01 FDA UDI
- Primary DI / UDI-DI
- B24225TSHHUE010 FDA UDI
- FDA Product Code
- JLW FDA UDI
- GMDN Term
- Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1690 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Thyroid Stimulating Hormone (TSH) ELISA by American Laboratory Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- American Laboratory Products Company
Sources (1)
- FDA UDI 4146ee1e-0d97-4368-ae63-166345d63bd5 37 fields · synced May 30, 2026